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SwishKit for Mechanical Ventilation Complications (EASIER Trial)
N/A
Recruiting
Led By Marcelo Gama de Abreu, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults, 18 years or older
Intubated with an oral endotracheal tube and expected to remain intubated for at least 2 days.
Must not have
Maxillofacial trauma precluding standard oral care techniques
Orofacial edema precluding access for oral care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 days after enrolment
Awards & highlights
No Placebo-Only Group
Summary
This trial is going to compare the effectiveness of two different oral care treatments in patients who have a tube in their throat. The goal of the trial is to see which treatment can reduce the amount of bacteria
Who is the study for?
This trial is for patients who are intubated in intensive care and may have complications from mechanical ventilation or oral bacterial infections. Participants must be able to give consent themselves or through a legal representative.
What is being tested?
The study is testing the effectiveness of a new device called Swiftsure SwishKit, used alongside standard oral care, in reducing bacteria in the mouth of intubated ICU patients compared to just standard oral care.
What are the potential side effects?
Since this trial involves an oral hygiene device plus usual care, side effects might include discomfort in the mouth or an allergic reaction to materials in the SwishKit.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am on a breathing machine with a tube in my mouth and will be for at least 2 more days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot perform standard oral care due to facial injury.
Select...
I have swelling in my face that makes it hard to care for my mouth.
Select...
I cannot be positioned with my head lower than my feet due to health issues.
Select...
I have an injury or infection in my throat.
Select...
I have been on a breathing machine for over a day within the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 days after enrolment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 days after enrolment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bacterial load in the oropharyngeal space
Secondary study objectives
16S rRNA sequencing of bacteria
Colony-Forming Units/milliliter (ml) (CFU/ml)
Colony-Forming Units/milliliter (ml) (CFU/ml) and 16S rRNA
Other study objectives
Clinician Perception of Treatment Use/Efficacy
Feasibility aims
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SwishKit + Oral care treatment as usualExperimental Treatment1 Intervention
SwishKit + Oral care Treatment as usual (TAU)
Group II: Oral care treatment as usualActive Control1 Intervention
Oral care Treatment as usual (TAU)
Find a Location
Who is running the clinical trial?
SwiftsureUNKNOWN
The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,451 Total Patients Enrolled
Marcelo Gama de Abreu, MDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
922 Total Patients Enrolled